Sentences with phrase «reaction to drug company»

While the Food and Drug Administration (FDA) recommends reporting the adverse reactions to the drug company itself, it's questionable whether those reports get to the FDA to be recorded.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Little coverage is given to such grim statistics by governments or pharmaceutical companies, so patients and their doctors are not primed to be as vigilant as they should be, and adverse drug reactions (ADRs) remain seriously under - recognised and under - reported.

The punishment, imposed in August but only made public today, is apparently the most severe reaction by NIH so far to a Senate investigation of NIH - funded researchers who may have failed to report all of their income from drug companies.

Sigman is collaborating with a major pharmaceutical company to use the new technique to improve chemical reactions for drug manufacturing.

By revealing skin sensitisation or an adverse reaction that may not be identified by use of an animal or computer model, the assay can provide vital information which will allow a drug company to make informed decisions earlier saving significant development costs.

The chemical reactions she has developed are widely used throughout the pharmaceutical industry to create new drug candidates, are being studied by chemical companies interested in accessing important chemicals used in farming, and are being utilized to prepare a type of chemical (tracer) that allows doctors to view the heart's sympathetic nervous system through positron emission tomography (PET) scans.

If you or your veterinarian suspects that an adverse reaction is related to the use of an arthritis medicine or any drug, it should be reported to the pharmaceutical company.

The insurance company took the position that, because Conners had failed to follow medical advice during his recovery from the first surgery, his negligence (and not the accident) was the cause of the nonunion, the revision surgery, and the resulting drug reaction.

To boost profits, pharmaceutical companies are not always forthright about potential reactions and side effects of certain drugs.

Medications prescribed inappropriately can trigger life - threatening adverse reactions; pharmaceutical companies sometimes downplay a drug's side effects or fail to adequately test a product before it goes to market.

Medications can cause drug interactions or other adverse reactions if prescribed inappropriately; pharmaceutical companies may fail to adequately test a drug before it goes to market.

Pharmaceutical companies know that a serious drug reaction can prove catastrophic in some cases and it is their job to make sure that the medications that they make, distribute, and sell are not dangerous drugs.

Professional Duties & Responsibilities Biomedical and biotechnology engineer with background in design of biomaterials, biosensors, drug delivery devices, microfrabrication, and tissue engineering Working knowledge of direct cell writing and rapid prototyping Experience fabricating nanocomposite hydrogel scaffolds Proficient in material analysis, mechanical, biochemical, and morphological testing of synthetic and biological materials Extensive experience in bio-imaging processes and procedures Specialized in mammalian, microbial, and viral cell culture Working knowledge of lab techniques and instruments including electrophoresis, chromatography, microscopy, spectroscopy, PCR, Flow cytometery, protein assay, DNA isolation techniques, polymer synthesis and characterization, and synthetic fiber production Developed strong knowledge of FDA, GLP, GMP, GCP, and GDP regulatory requirements Created biocompatible photocurable hydrogels for cell immobilization Formulated cell friendly prepolymer formulation Performed surface modification of nano - particle fillers to enhance their biocompatibility Evaluated cell and biomaterial interaction, cell growth, and proliferation Designed bench - top experiments and protocols to simulate in vivo situations Designed hydrogel based microfluidic prototypes for cell entrapment and cell culture utilizing computer - aided robotic dispenser Determined various mechanical, morphological, and transport properties of photocured hydrogels using Instron, FTIR, EDX, X-ray diffraction, DSC, TGA, and DMA Assessed biocompatibility of hydrogels and physiology of entrapped cells Evaluated intracellular and extracellular reactions of entrapped cells on spatial and temporal scales using optical, confocal, fluorescence, atomic force, and scanning electron microscopies Designed various biochemical assays Developed thermosensitive PET membranes for transdermal drug delivery application using Gamma radiation induced graft co-polymerization of N - isopropyl acylamide and Acrylic acid Characterized grafted co-polymer using various polymer characterization techniques Manipulated lower critical solution temperature of grafted thermosensitive co-polymer Loaded antibiotic on grafted co-polymer and determined drug release profile with temperature Determined biomechanical and biochemical properties of biological gels isolated from marine organisms Analyzed morphological and mechanical properties of metal coated yarns using SEM and Instron Performed analytical work on pharmaceutical formulations using gas and high performance liquid chromatography Performed market research and analysis for medical textile company Developed and implement comprehensive marketing and sales campaign